Emergent BioSolutions Inc. announced that it has signed an agreement to provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials and an initial capacity reservation.
“Emergent is driven by our desire to advance solutions that will make an impact on this pandemic,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “Sharing a passion for science, we are encouraged by AstraZeneca’s investigational COVID-19 vaccine and look forward to supporting its continued progress.”
The adenovirus vector-based vaccine candidate, AZD1222, was co-invented by the University of Oxford and its spin-out company, Vaccitech, and licensed by AstraZeneca. The vaccine candidate is currently in clinical trials. It is one of the candidates funded and supported by Operation Warp Speed (OWS), the U.S. government’s program to accelerate the development, manufacturing, and distribution of COVID-19 medical countermeasures that aims to have substantial quantities of a safe and effective vaccine available.
Syed T. Husain, senior vice president and CDMO business unit head at Emergent, stated, “As COVID-19 vaccine candidates progress through the pipeline, Emergent stands ready alongside leading innovators to rapidly deploy our CDMO services to help meet the substantial demand for a vaccine – anchored on our foundational expertise in development and manufacturing and propelled by our commitment to our mission – to protect and enhance life.”
This agreement follows and is in addition to the landmark public-private CDMO partnership between Emergent and the Biomedical Advanced Research and Development Authority (BARDA) announced in June to pave the way for OWS high-priority innovators.
Activities under this agreement will be performed at Emergent’s Baltimore Bayview facility, where certain manufacturing capacity reserved by BARDA through the CDMO task order issued to Emergent under OWS will be used. Emergent’s Baltimore Bayview facility is a designated Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of Health and Human Services (HHS) designed for rapid manufacturing of large quantities of vaccines and treatments during public health emergencies.
The CIADM has unique capabilities across four independent suites to produce at clinical scale to get candidates rapidly into the clinic, while at the same time scaling up to enable large-scale manufacturing to up to 4000L to prepare for production of commercial volumes to meet customer demand. The CIADM has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis, based upon the platform technology being used.